Class 100,000 Clean Room Apparel Requirements

Can someone please tell me the apparel requirements for a Class 100,000 clean room?
Please provide your response for the following apparel

• Lab Coat or Coverall?
• Gloves
• Bouffant Caps
• Beard Covers
• Shoe covers

I'm new to clean rooms. So if somebody can help me decide the apparel requirements I would be thankful.

Hi,
I think i depends on the total package of the apparel as well as consideration of other requirements (like ESD, humidity, etc).
Here is what we use.

Top to bottom (inward to upward):
Bouffant Cap
Face Mask
Hood (Overall Cover for the Head)
Gloves
Booties (from below the knee to the whole of the feet)
Overall (for the whole Body)
cleanroom shoes

aproddutoor said:

Can someone please tell me the apparel requirements for a Class 100,000 clean room?
Please provide your response for the following apparel

• Lab Coat or Coverall?
• Gloves
• Bouffant Caps
• Beard Covers
• Shoe covers

I'm new to clean rooms. So if somebody can help me decide the apparel requirements I would be thankful.

Click to expand...

Refer my existing post Minimum Gowning Requirements for ISO Class 8

bio_subbu said:

Refer my existing post Minimum Gowning Requirements for ISO Class 8

Click to expand...

Thanks for replying.
I saw your attachment posted on the other thread, it was helpful.

Hello to all
I would appreciate any feedback on the following:

We are a medical device manufacturer in a cleanroom class 8 (100,000) and would like to know what is the commom practice when it comes to the type of clothes permotted under the frock. For example the use of jeans, shorts, etc.

Is is allowed to have part of the body expossed like for example using shorts pants but the frock length is until the knees, ect.

Thanks for the feedback.

bio_subbu said:

Refer my existing post Minimum Gowning Requirements for ISO Class 8

Click to expand...

Howdy,
Perhaps just terminology or verbage, but I got caught up in the "recommended" vs. "Requirements"...

I am currently sitting in a Class 100,000 clean room. I have none of the things in the above referenced requirement list in place. The last measure in here had a highest particle count (0.5um+) of 1100.

The requirement of a class 100,000 clean room is that it measures out at <100,000. All the rest is preference.

What preferences you can entertain have a great deal to do with airflow, % inlet coverage, traffic, held processes, etc. We wear Tyvek coats not because we need them, but as a visual 'tone' for employees and customers to not be slobs. If they were slobs, we might end up at 20,000 particle count...still a viable 100K clean room.

My house complies with a 100K cleanroom requirement. (No kids, no dogs helps to keep it a bit cleaner )

If the process or regulation requires 100K, keep the requirement as your focus...the dress is a tool to achieve the requirement, a tool that costs money. More dress = more cost.

Bottom line is to make sure the requirement is met, not that a specific tool is used a specific way. Rent a particle counter and see what is needed.

csterling said:

We are a medical device manufacturer in a cleanroom class 8 (100,000) and would like to know what is the commom practice when it comes to the type of clothes permotted under the frock. For example the use of jeans, shorts, etc.

Is is allowed to have part of the body expossed like for example using shorts pants but the frock length is until the knees, ect.

Click to expand...

ISO 14644-5 Annex C provides informative recommendations for Personnel Clothing and personal items. Specifically there is risk to wearing natural fibers such as wool or cotton sheding contamination. If workers are not wearing undergarments and have legs exposed, there is an even greater risk for contamination from shed skin. If the need for undergarments is decided by the manufacturer, it is recommended to select woven, artificial fibers.

My personal feeling is if you meet the monitoring requirements consistantly, your undergarment practices are fine. I wouldnt want to risk the contamination of a clean room with flaking skin considering the cost of investment if contamination were to occur. But ultimately, I think the regulation for undergaments in your type of cleanroom leaves it up to the manufacturer.

ISO 8 (Fed 100k) is technically the least stringent class, in terms of particle counts. Like others have suggested late in the thread, there are more "Recommended" pieces of apparel than required.

Do these, and you'll be well covered (pun intended?) in terms of contamination through personnel clothing / skin / scalp / hair sloughing & shedding.

-Disposable Bouffant cap.
-Disposable Beard cover.
-Washable Frock / Smock.
-Disposable cleanroom compliant gloves.
-Disposable shoe covers.